# FDA 483 - Biosearch Medical Products, Inc. - October 11, 2022

Source: https://www.globalkeysolutions.net/records/483/biosearch-medical-products-inc/8070a0cb-4e6a-4dfa-958f-7c388caacf3c

> FDA 483 for Biosearch Medical Products, Inc. on October 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biosearch Medical Products, Inc.
- Inspection Date: 2022-10-11
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Biosearch Medical Products, Inc. in Concord, NC, a manufacturer of medical device coatings, revealed significant deficiencies in their quality system. The firm failed to establish and maintain critical procedures for process validation, supplier evaluation, incoming product acceptance, device master records, device history records, and quality audits. These issues indicate a lack of fundamental controls necessary for ensuring product quality and regulatory compliance.

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/biosearch-medical-products-inc/f2b5a95b-8819-4367-9ca2-d9fc297dbef2

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7